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Vertex Pharmaceuticals Incorporated Message Board

  • aurorainsider aurorainsider Apr 23, 2013 7:10 AM Flag

    More on Hep C competition

    - A combination of five oral drugs being tested by AbbVie Inc cured at least 88 percent of new patients with hepatitis C after only eight weeks of treatment, without raising significant safety issues, researchers said on Tuesday.

    The latest findings from an ongoing trial sponsored by AbbVie, called Aviator, also showed that 96 percent of patients taking the five medicines for 12 weeks eliminated the virus, as assessed by blood tests 24 weeks after they stopped treatment.

    If the virus is undetectable 24 weeks after completing treatment, known as SVR 24, a patient is considered cured.

    The latest results were deemed little different than the 99 percent sustained virologic response (SVR) rate reported in October, for patients evaluated 12 weeks after completing 12 weeks of the five-drug treatment regimen.

    "We are pleased that the data remain consistent and robust," said Dr. Kris Kowdley, who is presenting the data this week at a meeting of the European Association for the Study of the Liver (EASL) in Amsterdam.

    "The data confirm that the 12-week treatment appears to be optimal, but certainly we are still very pleased with ... data for the eight-week treatment," Kowdley said in an interview.

    AbbVie is deemed to be in a horse race with Gilead Sciences Inc to be first to market with an all-oral treatment for the serious liver disease, as companies work to eliminate difficult-to-tolerate intravenous interferon from the regimen, while raising cure rates and shortening treatment duration.

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    • On April 8, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sofosbuvir for the treatment of HCV infection. The data submitted in the NDA support the use of sofosbuvir and RBV as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and peg-IFN for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.
      Gilead plans to file for regulatory approval of sofosbuvir in other geographies, including the European Union, in the second quarter of 2013. The European Medicines Agency (EMA) has accepted Gilead’s request for accelerated assessment for sofosbuvir, a designation that is granted to new medicines of major public health interest. Accelerated assessment could shorten the EMA’s review time of sofosbuvir by two months. Granting of accelerated assessment does not guarantee a positive opinion from the CHMP or approval by the European Commission.

 
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